Portugal to also benefit from EU-US mutual recognition agreement for inspections

News 20/09/2018

The mutual recognition agreement between the European Union (EU) and the United States (US) to recognise inspections of manufacturing sites for human medicines conducted in their respective territories has made further progress. The US Food and Drug Administration (FDA) confirmed on 14 September 2018 the capability of one additional EU Member State (Portugal) to carry out good manufacturing practice (GMP) inspections at a level equivalent to the US. There are now a total of 15 Member States whose inspection results the FDA can rely on to replace their own inspections.

In June 2017, the European Commission confirmed that the FDA has the capability, capacity and procedures in place to carry out GMP inspections at a level equivalent to the EU. Since 1 November 2017, EU Member States and the European Medicines Agency (EMA) can rely on inspection results from the FDA to replace their own inspections. On 1 November 2017, the FDA confirmed the capability of eight EU Member States. Four further EU Member States were recognised by the FDA on 1 March 2018 and two on 1 June 2018.

Plans for the agreement to be operational in all EU Member States by 15 July 2019 are on track.

The agreement is underpinned by robust evidence on both sides of the Atlantic that the EU and the US have comparable regulatory and procedural frameworks for inspections of manufacturers of human medicines. Teams from the European Commission, EU national competent authorities, EMA and the FDA have been auditing and assessing the respective supervisory systems since May 2014, and are working closely together to reach the agreement's milestones.